A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

NCT ID: NCT03653507

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2026-03-31

Brief Summary

Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called GEJ cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor.

There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat stomach cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the people taking part in those countries will leave this study and receive licensed zolbetuximab.

The main aim(s) of the study is(are) to determine the efficacy of zolbetuximab combined with chemotherapy compared to a placebo combined with chemotherapy in treating adults with Claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies but have not been treated with chemotherapy for their cancer. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.

The study treatments are either zolbetuximab with chemotherapy or placebo with chemotherapy. People who take part will receive just one of the treatments by chance. Study treatment will be double-blinded. That means that the people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in cycles. The study treatment is given to people slowly through a tube into a vein. This is called an infusion. The chemotherapy is called CAPOX (capecitabine and oxaliplatin) and will be given as an infusion and also as tablets. People will have 1 infusion of either zolbetuximab or placebo together with oxaliplatin chemotherapy in 3-week (21-day) cycles. People will also take 1 tablet of capecitabine (chemotherapy) twice a day for the first 2 weeks (14 days) of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the treatment, or they need to start another cancer treatment. People will receive CAPOX for up to about 6 months (8 treatment cycles). After the 6 months, people may receive capecitabine chemotherapy only, until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will visit the clinic on certain days during their treatment. The study doctors will check if people had any medical problems from zolbetuximab or the other study treatments. Also, people in the study will have health checks. On some visits, they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample after their study treatment has finished. People will visit the clinic within 7 days after they stop their study treatment. People will be asked about any medical problems and will have a health check. People who start treatment with licensed zolbetuximab will not need to attend the clinic for further visits and will receive standard of care health checks. People who continue study treatment will visit the clinic at 1 and 3 months after they stop their study treatment. They will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

Detailed Description

After the marketing approval in Japan on 26 Mar 2024, this study continued as "post marketing clinical study" in Japan. In the rest of the countries which participated in this study, this study continued as clinical study.

Conditions

Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zolbetuximab plus CAPOX

Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.

Group Type: EXPERIMENTAL

zolbetuximab

Intervention Type: DRUG

Zolbetuximab were administered as a minimum 2-hour IV infusion.

oxaliplatin

Intervention Type: DRUG

Oxaliplatin were administered as a 2-hour IV infusion.

capecitabine

Intervention Type: DRUG

Capecitabine were administered orally twice daily (bid).

Placebo plus CAPOX

Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 bid on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21 days.

Group Type: PLACEBO_COMPARATOR

oxaliplatin

Intervention Type: DRUG

Oxaliplatin were administered as a 2-hour IV infusion.

capecitabine

Intervention Type: DRUG

Capecitabine were administered orally twice daily (bid).

placebo

Intervention Type: DRUG

Placebo were administered as a minimum 2-hour IV infusion.

Interventions

zolbetuximab

Zolbetuximab were administered as a minimum 2-hour IV infusion.

Intervention Type: DRUG

oxaliplatin

Oxaliplatin were administered as a 2-hour IV infusion.

Intervention Type: DRUG

capecitabine

Capecitabine were administered orally twice daily (bid).

Intervention Type: DRUG

placebo

Placebo were administered as a minimum 2-hour IV infusion.

Intervention Type: DRUG

Other Intervention Names

IMAB362

Eligibility Criteria

Inclusion Criteria

• A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:

• Not a woman of childbearing potential (WOCBP) OR
• WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
• Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study treatment administration.
• Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs.
• A male subject with female partner(s) of childbearing potential:

• must agree to use contraception during the treatment period and for 6 months after the final study treatment administration.
• A male subject must not donate sperm during the treatment period and for 6 months after the final study treatment administration.
• Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study treatment administration.
• Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma.
• Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization.
• Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, ≤ 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
• Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
• Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.)
• Subject has ECOG performance status 0 or 1.
• Subject has predicted life expectancy ≥ 12 weeks.
• Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.

• Hemoglobin (Hb) ≥ 9 g/dl. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb ≥ 9 g/dL.
• Absolute Neutrophil Count (ANC) ≥ 1.5x10^9/L
• Platelets ≥ 100x10^9/L
• Albumin ≥ 2.5 g/dL
• Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN without liver metastases (or ≤ 5 x ULN if liver metastases are present)
• Estimated creatinine clearance ≥ 30 mL/min
• Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x ULN (except for subjects receiving anticoagulation therapy)

Exclusion Criteria

• Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to randomization.
• Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has not recovered from any related toxicity.
• Subject has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to randomization.
• Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.
• Subject has received other investigational agents or devices within 28 days prior to randomization.
• Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
• Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment.
• Subject has prior severe allergic reaction or intolerance to any component of CAPOX.
• Subject has known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
• Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation.
• Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements.

• For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded.
• Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible.
• Subjects treated for HCV with undetectable viral load results are eligible.
• Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization.
• Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.
• Subject has significant cardiovascular disease, including any of the following:

• Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization.
• History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes
• QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects
• History or family history of congenital long QT syndrome
• Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible).
• Subject has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis from gastric/GEJ cancer..
• Subject has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
• Subject has had a major surgical procedure ≤ 28 days prior to randomization.

• Subject is without complete recovery from a major surgical procedure ≤ 14 days prior to randomization.
• Subject has psychiatric illness or social situations that would preclude study compliance.
• Subject has another malignancy for which treatment is required.
• Subject has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

Pacific Cancer Care

Monterey, California, United States

University of Kansas Cancer Center and Medical Pavilion

Fairway, Kansas, United States

Ochsner Clinic CCOP

New Orleans, Louisiana, United States

New Mexico Oncology Hematology

Albuquerque, New Mexico, United States

Weill Cornell Medical College (WCMC)

New York, New York, United States

Montefiore Medical Center (MMC)

The Bronx, New York, United States

Prisma Health Cancer Institute

Boiling Springs, South Carolina, United States

Parkland Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Houston Methodist Cancer Center and Institute of Academic Medicine - Oncology

Houston, Texas, United States

Utah Cancer Specialist

Salt Lake City, Utah, United States

Site AR54009

Buenos Aires, , Argentina

Site GB44005

Northwood, , Argentina

Site AR54006

Pergamino, , Argentina

Site AR54001

San Miguel de Tucumán, , Argentina

Site AR54004

San Miguel de Tucumán, , Argentina

Site AR54003

Viedma, , Argentina

Site CA15003

Chicoutimi, Quebec, Canada

Site CA15002

Rimouski, Quebec, Canada

Site CA15004

Calgary, , Canada

Site CN86034

Fuzhou, Fujian, China

Site CN86037

Fuzhou, Fujian, China

Site CN86032

Haikou, Hainan, China

Site CN86012

Zhengzhou, Henan, China

Site CN86029

Changsha, Hunan, China

Site CN86043

Hengyang, Hunan, China

Site CN86027

Suzhou, Jiangsu, China

Site CN86046

Wuxi, Jiangsu, China

Site CN86007

Hangzhou, Zhejiang, China

Site CN86044

Baoding, , China

Site CN86035

Beijing, , China

Site CN86050

Beijing, , China

Site CN86025

Bengbu, , China

Site CN86002

Changchun, , China

Site CN86049

Changchun, , China

Site CN86053

Changchun, , China

Site CN86021

Changzhou, , China

Site CN86039

Chengdu, , China

Site CN86052

Dalian, , China

Site CN86054

Dalian, , China

Site CN86015

Fuzhou, , China

Site CN86001

Guangzhou, , China

Site CN86042

Guangzhou, , China

Site CN86051

Haebrin, , China

Site CN86036

Hangzhou, , China

Site CN86038

Linyi, , China

Site CN86016

Nanjing, , China

Site CN86045

Nanning, , China

Site CN86014

Shanghai, , China

Site CN86026

Shantou, , China

Site CN86047

Shenyang, , China

Site CN86017

Shijiazhuang, , China

Site CN86009

Tianjin, , China

Site CN86040

Tianjin, , China

Site CN86031

Ürümqi, , China

Site CN86004

Wuhan, , China

Site CN86005

Wuhan, , China

Site CN86013

Xi'an, , China

Site CN86030

Xiamen, , China

Site CN86011

Xuzhou, , China

Site CN86024

Zhengzhou, , China

Site HR38501

Varaždin, , Croatia

Site HR38502

Zagreb, , Croatia

Site HR38503

Zagreb, , Croatia

Site GR30001

Athens, , Greece

Site GR30004

Heraklion, , Greece

Site GR30003

Larissa, , Greece

Site GR30005

Neo Faliro, Piraeus, , Greece

Site GR30007

Rio Patras, , Greece

Site GR30002

Thessaloniki, , Greece

Site GR3006

Thessaloniki, , Greece

Site IE35301

Dublin, , Ireland

Site IE35302

Dublin, , Ireland

Site JP81007

Fukuoka, Fukuoka, Japan

Site JP81008

Akashi, Hyōgo, Japan

Site JP81003

Kawasaki, Kanagawa, Japan

Site JP81001

Yokohama, Kanagawa, Japan

Site JP81010

Suita, Osaka, Japan

Site JP81005

Utsunomiya, Tochigi, Japan

Site JP81002

Chiba, , Japan

Site JP81006

Kashiwa, , Japan

Site JP81004

Kita-gun, , Japan

Site JP81012

Kōtoku, , Japan

Site JP81009

Matsuyama, , Japan

Site JP81011

Tsukiji, , Japan

Site MY60001

George Town, , Malaysia

Site MY60004

Kota Kinabalu, , Malaysia

Site MY60002

Kuala Lumpur, , Malaysia

Site MY60003

Kuala Lumpur, , Malaysia

Site MY60005

Kuala Lumpur, , Malaysia

Site NL31004

Groningen, , Netherlands

Site NL31003

Tilburg, , Netherlands

Site PT35109

Braga, , Portugal

Site PT35110

Coimbra, , Portugal

Site PT35111

Guimarães, , Portugal

Site PT35102

Lisbon, , Portugal

Site PT35106

Lisbon, , Portugal

Site PT35105

Porto, , Portugal

Site PT35108

Porto, , Portugal

Site PT35104

Santa Maria da Feira, , Portugal

Site PT35101

Setúbal, , Portugal

Site PT35107

Vila Real, , Portugal

Site RO40002

Bucharest, , Romania

Site RO40005

Cluj-Napoca, , Romania

Site RO40007

Cluj-Napoca, , Romania

Site RO40003

Craiova, , Romania

Site RO40004

Floreşti, , Romania

Site RO40001

Iași, , Romania

Site RO40006

Iași, , Romania

Site RO40008

Timișoara, , Romania

Site KR82002

Daegu, , South Korea

Site KR82006

Goyang-si, , South Korea

Site KR82007

Gyeonggi-do, , South Korea

Site KR82014

Incheon, , South Korea

Site KR82008

Jeollanam-do, , South Korea

Site KR82010

Jeonju, , South Korea

Site KR82011

Seongnam-si, , South Korea

Site KR82001

Seoul, , South Korea

Site KR82003

Seoul, , South Korea

Site KR82012

Seoul, , South Korea

Site KR82013

Seoul, , South Korea

Site KR82015

Seoul, , South Korea

Site KR82009

Suwon, , South Korea

Site ES34005

A Coruña, , Spain

Site ES34006

Barcelona, , Spain

Site ES34009

Barcelona, , Spain

Site ES34010

Barcelona, , Spain

Site ES34001

Elche, , Spain

Site ES34002

Madrid, , Spain

Site ES34003

Madrid, , Spain

Site ES34008

Madrid, , Spain

Site ES34013

Madrid, , Spain

Site ES34011

Málaga, , Spain

Site ES34004

Pamplona, , Spain

Site ES34007

Valencia, , Spain

Site ES34012

Valencia, , Spain

Site TW88602

Kaohsiung City, , Taiwan

Site TW88603

Taichung, , Taiwan

Site TW88604

Taipei, , Taiwan

Site TW88605

Tianan, , Taiwan

Site TH66002

Bangkok, , Thailand

Site TH66005

Bangkok, , Thailand

Site TH66007

Bangkok, , Thailand

Site TH66009

Bangkok, , Thailand

Site TH66011

Laksi, , Thailand

Site TH66001

Muang, , Thailand

Site TH66003

Muang, , Thailand

Site TH66006

Pathum Thani, , Thailand

Site TH66010

Pathumwan, , Thailand

Site TH66004

Songkhla, , Thailand

Site TH66008

Vadhana, , Thailand

Site TR90008

Pendik, Istanbul, Turkey (Türkiye)

Site TR90003

Atakum, , Turkey (Türkiye)

Site TR90004

Balcalı, , Turkey (Türkiye)

Site TR90012

Bornova, , Turkey (Türkiye)

Site TR90001

Bursa, , Turkey (Türkiye)

Site TR90002

Istanbul, , Turkey (Türkiye)

Site TR90010

Istanbul, , Turkey (Türkiye)

Site TR90015

Istanbul, , Turkey (Türkiye)

Site TR90007

Konya, , Turkey (Türkiye)

Site TR90013

Konyaalti, , Turkey (Türkiye)

Site TR90011

Malatya, , Turkey (Türkiye)

Site GB44002

Bristol, , United Kingdom

Site GB44004

Cardiff, , United Kingdom

Site GB44001

London, , United Kingdom

Countries

United States; Argentina; Canada; China; Croatia; Greece; Ireland; Japan; Malaysia; Netherlands; Portugal; Romania; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future Oncol. 2024;20(26):1861-1877. doi: 10.1080/14796694.2024.2342107. Epub 2024 May 24.

Reference Type: DERIVED

PMID: 38861294 (View on PubMed)

Shah MA, Shitara K, Ajani JA, Bang YJ, Enzinger P, Ilson D, Lordick F, Van Cutsem E, Gallego Plazas J, Huang J, Shen L, Oh SC, Sunpaweravong P, Soo Hoo HF, Turk HM, Oh M, Park JW, Moran D, Bhattacharya P, Arozullah A, Xu RH. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med. 2023 Aug;29(8):2133-2141. doi: 10.1038/s41591-023-02465-7. Epub 2023 Jul 31.

Reference Type: DERIVED

PMID: 37524953 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-000519-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTR20190261

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2080224166

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-511648-16-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

8951-CL-0302

Identifier Type: -

Identifier Source: org_study_id